Recall Z-2071-2017 ยท PGW Ear, Nose, And Throat Stereotaxic Instrument
Stryker Instruments Div. of Stryker Corporation
Stryker PROFESS Registration Kit. The Stryker PROFESS Registration Kit is a member of the Navigation portfolio and is used as an intraoperative guidance system to enable intranasal and sinus computer-assisted surgery. The system is comprised of PROFESS Registration Stickers, a PROFESS Patient Tracker, and a PROFESS Adaptor Cable.
| Date | Apr 19, 2017 (initiated Mar 10, 2017) |
| Status | Terminated |
| Reason | Product shipped proximate to or past the expiration date listed on the product label. |
| Root cause | Storage |
| Action | Stryker sent an "URGENT MEDICAL DEVICE RECALL NOTIFICATION" dated March 10, 2017, to the affected customers via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Actions to be Taken by the Customer/User: 1. Immediately review this Recall Notification. 2. Immediately check all stock areas and/or operating room storage for affected equipment. Quarantine and discontinue use of any recalled PROFESS Registration Kits. 3. Complete the enclosed |
| Quantity | 65 |
| Distribution | US (nationwide) Distribution to the states of : CA, CT, GA, IL, IN, MA, MD, NC, OH, PA, TN, and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K141551 | PROFESS SOFTWARE, PROFESS CURVED 70 (DEGREES) SUCTION, PROFESS CURVED 70 (DEGREES) SUCTION, PROFESS CURVED 90 (DEGREES) Stryker Corporate, Sep 8, 2014 |